In these slides you will learn how hyperlinks, bookmarks and password in your PDF files can result in validation errors of your application for licensing by Health Canada and therefore delay the review process.

1. Ways to Avoid Navigation and
PDF errors during ECTD
Validation: Health Canada
Job Kiaira

2. Outline
Passwords and encryption
Bookmarks
Hyperlinks

3. Corrupt or unreadable PDF
documents
­No corrupt or unreadable PDF documents should be
submitted
­All files should be checked
­Some authors tend to protect their files. Password protection
or encryption is not allowed as it will result in an error.
­All passwords should be removed.
­No security settings or password protection for PDF files
should be included.
­Security fields should be set to allow printing, changes to the
document, selecting text and graphics, and adding or changing
notes and form fields

4. Bookmarks

5. No absolute bookmarks
­All bookmarks should have relative paths.
­Non­relative bookmarks in PDF documents
including the broken ones will not be accepted
and will result in error message .
­If a document uses absolute paths then it cannot
be moved to another computer or written on CD
without breaking the links.

6. Bookmarks destination
For all bookmarks, the named destination or
destination page must exist.
Invalid destinations will be reported as error

7. Inactive Bookmarks
All inactive bookmarks in PDF documents will be
flagged with error messages

8. Broken Bookmarks
All broken intra­sequence and intra­application
bookmarks in PDF documents will be flagged
with error

9. External Bookmarks
Web link bookmarks or e­mail bookmarks
in PDF documents should not be
submitted
All external bookmarks (other than
certain web links and e­mail links) from
PDF documents will also be flagged with
error

10. Bookmarks multi action
No bookmark should have multiple actions as
they will cause several PDF files to open
resulting in validation error

11. Hyperlinks

12. Relative or absolute hyperlinks?
Absolute hyperlinks from PDF
documents will result in validation error.
All hyperlinks should have a relative
path .

13. Inactive and broken Hyperlinks
Inactive hyperlinks are not allowed. They should be
checked early.
Broken PDF inter­application, intra­application and
intra­sequence hyperlinks are also not allowed and
they will result in validation error.

14. External Hyperlinks
­External hyperlinks currently result in a validation error
that would normally cause a regulatory transaction to fail
validation.
­Including some links to a web page (such as sponsors
own websites or e­mail addresses) are acceptable in
some labelling documents and literature references.
­Any external links to information necessary to the review
process will result in a validation failure.
­Information relating to the review process should be
included within the regulatory activity as a PDF or another
appropriate file type.

15. Hyperlinks with multi action
One hyperlink should result in a single action
such as opening a file.
A hyperlink should not result in opening
several files at the same time.
Hyperlinks with multiple actions will result in
validation error.

16. PDF documents with attachments
PDF documents with attachments will not pass validation.
They will be flagged with error.

17. REFERENCES
http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf
http://www.hc­sc.gc.ca/dhp­mps/prodpharma/applic­demande/guide­ld/ectd
/ectd_valid_rev_v0.5a_notice_avis­eng.php
http://www.hc­sc.gc.ca/dhp­mps/alt_formats/hpfb­dgpsa/pdf/prodpharma
/prep_ectd_format­eng.pdf
FOR MORE INFORMATION
or help with eCTD
click here or go to our
website:
http://regulatoryaffairs­consultants.ca/ectd­format­training/